Compare Propofol to Fentanyl and Midazolam for Colonoscopy

This study is currently recruiting participants.
Verified January 2014 by Saint Joseph Mercy Health System
Sponsor:
Information provided by (Responsible Party):
Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier:
NCT01488045
First received: December 1, 2011
Last updated: January 20, 2014
Last verified: January 2014

December 1, 2011
January 20, 2014
June 2011
January 2014   (final data collection date for primary outcome measure)
Patient satisfaction [ Time Frame: Survey completed 30-45 minutes following colonoscopy procedure ] [ Designated as safety issue: No ]
Measured by the patient
Same as current
Complete list of historical versions of study NCT01488045 on ClinicalTrials.gov Archive Site
Patient discomfort [ Time Frame: Survey completed immediately following colonoscopy procedure ] [ Designated as safety issue: No ]
Measured by the endoscopist
Same as current
Not Provided
Not Provided
 
Compare Propofol to Fentanyl and Midazolam for Colonoscopy
Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.

The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician.

Background The use of colonoscopy has become an important diagnostic and therapeutic tool in the evaluation of multiple medical conditions of the gastrointestinal tract. Despite its widespread use, there continues to be debate concerning the best pharmacologic approach to patient satisfaction and discomfort of the procedure and to minimize side effects.

Aim Two standard pharmacologic (Propofol or Fentanyl and low-dose Midazolam) approaches for colonoscopy will be evaluated systematically to determine if these two approaches are equivalent in terms of patient rating of satisfaction and patient discomfort to the procedure and side effects

Study Design This is a prospective randomized study of 262 participants undergoing outpatient colonoscopy at an independent academic medical center. The primary outcome of this study is participant's satisfaction, and the secondary outcome is discomfort of the patient as perceived by the physician performing the procedure.

Other Variables of Interest.

  • Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge.
  • Difficulty of procedure rated by the physician on a scale of 0-10
  • Colonoscopy completion rates (intubation of cecum).
  • Complications including oxygen desaturation or hypotension.
  • Cost of the two medication regiments
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Colon Cancer
  • Rectal Cancer
  • Colonic Diverticulosis
  • Drug: Fentanyl
    Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.
    Other Names:
    • Durogesic
    • Duragesic
    • Matrifen
  • Drug: Propofol
    Propofol will be administered IV according to standard procedure for colonoscopy. The initial bolus of propofol will be up to 60 mg IV. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more sedation in 10-20 mg boluses.
    Other Name: Diprivan
  • Drug: Midazolam
    Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments.
    Other Name: Versed
  • Active Comparator: Fentanyl and Midazolam
    Fentanyl and Midazolam sedation for colonoscopy discomfort
    Interventions:
    • Drug: Fentanyl
    • Drug: Midazolam
  • Active Comparator: Propofol
    Propofol sedation for colonoscopy discomfort
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
290
June 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18
  • Elective outpatient colonoscopy
  • American Society of Anesthesiology Class (ASA) < IV

Exclusion Criteria:

  • Age < 18
  • Inpatient status
  • Emergency procedure
  • History of colonic or rectal resection
  • History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam
  • ASA of IV
  • Neurological deficit
  • Acute gastrointestinal bleeding
  • On anticoagulation agents
  • Noncompliance with bowel regiment
  • Pregnant women
  • Prisoners
Both
18 Years and older
No
Contact: Robert K Cleary, MD 734-712-8150 clearyrk@trinity-health.org
Contact: Janet Obear, RN 734-712-5194 obearj@trinity-health.org
United States
 
NCT01488045
RCCS 262
No
Saint Joseph Mercy Health System
Saint Joseph Mercy Health System
Not Provided
Principal Investigator: Robert Cleary, MD Saint Joseph Mercy Health System
Saint Joseph Mercy Health System
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP